Ciprofloxacin 0.3% + Dexamethasone 0.1% E/E prep
Indications
Ciprofloxacin 0.3% + Dexamethasone 0.1% E/E prep is used for:
Steroid responsive inflammatory ocular conditions, Otitis media, Otitis externa, Ocular inflammation associated with infection, Post-operative inflammation of ear and eye.
Adult Dose
For Eye: 1 drop to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.
For Ear: Acute otitis externa: 4 drops instilled into the affected ear 2 times daily for 7 days.
Frequency should be decreased gradually or warranted in clinical signs. Care should be taken not to discontinue therapy prematurely.
Child Dose
For Eye: 1 drop to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.
For Ear: Acute otitis media in pediatric patients with typanastomy tube: 4 drops instilled into the affected ear 2 times daily for 7 days.
Frequency should be decreased gradually or warranted in clinical signs. Care should be taken not to discontinue therapy prematurely.
<6 months: Not recommended
Renal Dose
Administration
Contra Indications
Known hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.
Precautions
Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation.
Patients wearing contact lenses must not use the drops during the time the lenses are worn.
Lactation: Unknown whether drug is excreted in milk; use not recommended
Pregnancy-Lactation
Pregnancy category: C
Lactation: Unknown whether drug is excreted in milk; use not recommended
Interactions
May increase plasma concentrations of CYP1A2 substrates (e.g. clozapine, ropinirole, theophylline). Enhances effect of oral anticoagulants (e.g. warfarin) and glibenclamide. Increased toxicity of methotrexate. Plasma concentrations may be increased by probenecid. Reduced absorption w/ oral multivitamins and mineral supplements containing divalent or trivalent cations (e.g. Fe, Zn, Ca) and antacids containing Al, Ca or Mg. Concomitant use w/ class IA antiarrhythmics (e.g. quinidine, procainamide), class III antiarrhythmics (e.g. amiodarone, sotalol), TCAs, macrolides and antipsychotics may result in additive effects on QT interval prolongation. Concurrent use w/ corticosteroids may increase risk of severe tendon disorders. Increased risk of CNS stimulation w/ NSAIDs. Altered serum concentrations of phenytoin.
Potentially Fatal: Marked elevation in serum levels of tizanidine which is associated w/ potentiated hypotensive and sedative effect.
Adverse Effects
Side effects of Ciprofloxacin 0.3% + Dexamethasone 0.1% E/E prep :
The most frequently reported drug-related adverse reactions seen with Ciprofloxacin are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, conjunctivitis/keratitis, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness have been received.
The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage, posterior sub capsular cataract formation, and delayed wound healing.
Mechanism of Action
Ciprofloxacin promotes breakage of double-stranded DNA in susceptible organisms and inhibits DNA gyrase, which is essential in reproduction of bacterial DNA.
Dexamethasone is a synthetic glucocorticoid which decreases inflammation by inhibiting the migration of leukocytes and reversal of increased capillary permeability. It suppresses normal immune response.